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	<title>Reglan Side Effects &#187; Tranzyme Pharam</title>
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		<title>New treatment for gastroparesis granted FDA &#8216;fast-track&#8217; status</title>
		<link>http://www.reglan-lawyer.net/news/2009/08/05/new-treatment-for-gastroparesis-granted-fda-fast-track-status/</link>
		<comments>http://www.reglan-lawyer.net/news/2009/08/05/new-treatment-for-gastroparesis-granted-fda-fast-track-status/#comments</comments>
		<pubDate>Wed, 05 Aug 2009 16:23:28 +0000</pubDate>
		<dc:creator>Jennifer Walker-Journey</dc:creator>
				<category><![CDATA[News]]></category>
		<category><![CDATA[black box warning]]></category>
		<category><![CDATA[diabetic gastroparesis]]></category>
		<category><![CDATA[FDA warning]]></category>
		<category><![CDATA[gastroparesis treatment]]></category>
		<category><![CDATA[lawyer]]></category>
		<category><![CDATA[metoclopramide]]></category>
		<category><![CDATA[Reglan]]></category>
		<category><![CDATA[Tranzyme Pharam]]></category>
		<category><![CDATA[TZP-101]]></category>
		<category><![CDATA[TZP-102]]></category>

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		<description><![CDATA[Tranzyme Pharma’s new drug to treat diabetic gastroparesis has been granted a fast-track designation by the Food and Drug Administration (FDA), allowing it faster access to FDA personnel as it moves through the approval process. The new medication, called TZP-102,  has just moved into phase II trials in humans. If the trials run smoothly, the [...]<p>SOURCE: <a href="http://www.reglan-lawyer.net">Reglan Side Effects</a> &rsaquo; <a href="http://www.reglan-lawyer.net/news/2009/08/05/new-treatment-for-gastroparesis-granted-fda-fast-track-status/">New treatment for gastroparesis granted FDA &#8216;fast-track&#8217; status</a></p>
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			<content:encoded><![CDATA[<p><strong><img class="alignleft size-thumbnail wp-image-299" title="gastroparesis" src="http://www.reglan-lawyer.net/media/2009/08/gastroparesis-150x150.jpg" alt="gastroparesis 150x150 New treatment for gastroparesis granted FDA fast track status" width="150" height="150" />Tranzyme Pharma’s</strong> new drug to treat <strong>diabetic gastroparesis</strong> has been granted a fast-track designation by the Food and Drug Administration (FDA), allowing it faster access to FDA personnel as it moves through the approval process. The new medication, called <strong>TZP-102</strong>,  has just moved into phase II trials in humans. If the trials run smoothly, the drug should enter phase III trials next year with approval by 2013 at the earliest. The fast-track designation is reserved for drugs that treat serious and unmet medical needs.<span id="more-293"></span></p>
<p><strong>TZP-102</strong> is an oral medication. <strong>Tranzyme’s</strong> equivalent medication, <strong>TZP-101</strong>, a drug given by IV in a hospital setting, has been put on hold by the company. While the drug showed promising results in phase II trials, the company hopes to buy time until the markets improve and the cost of capital drops.</p>
<p><strong>Diabetic gastroparesis</strong> is a disorder in which the stomach takes too long to empty its contents. It affects people with both type 1 and type 2 diabetes. The condition is often treated with <strong><a href="http://www.reglan-lawyer.net/tag/metoclopramide/" title="" rel="external">metoclopramide</a></strong>, sold in the U.S. under the brand name <strong><a href="http://www.reglan-lawyer.net/" title="" rel="external">Reglan</a></strong>. Earlier this year, the FDA required manufacturers of <a href="http://www.reglan-lawyer.net/tag/metoclopramide/" class="st_tag internal_tag" rel="tag" title="Posts tagged with metoclopramide">metoclopramide</a> to put a <a href="http://www.reglan-lawyer.net/tag/black-box-warning/" class="st_tag internal_tag" rel="tag" title="Posts tagged with black box warning">black box warning</a> on the  medication warning health care providers and consumers of the risk of a serious involuntary movement disorder known as <strong><a href="http://www.reglan-lawyer.net/reglan-side-effects/tardive-dyskinesia/" title="" rel="external">Tardive Dyskinesia</a></strong>.</p>
<p>Patients who suffer from Tardive Dyskinesia experience such as lip smacking, tongue thrusting, eye blinking and bulging, head jerking, facial grimacing, pucker and pursing of the lips and involuntary movements of the fingers. The condition is often irreversible even after medication has been stopped.</p>
<p>Analysts say a new treatment for <strong>diabetic gastroparesis</strong> would be welcome in an area where few treatments are currently available.</p>
<p>Source: Biz Journals</p>
<p>SOURCE: <a href="http://www.reglan-lawyer.net">Reglan Side Effects</a> &rsaquo; <a href="http://www.reglan-lawyer.net/news/2009/08/05/new-treatment-for-gastroparesis-granted-fda-fast-track-status/">New treatment for gastroparesis granted FDA &#8216;fast-track&#8217; status</a></p>
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